Principal Physician, Patient Safety

About the role

The Principal Physician, Patient Safety will lead the medical safety function for assigned products, ensuring compliance with global pharmacovigilance regulations and client guidelines. This senior position acts as a subject‑matter expert, mentors junior physicians, and provides thought leadership across therapeutic areas.

Key responsibilities

• Maintain comprehensive knowledge of adverse event profiles, labeling, and global drug safety regulations.
• Perform medical review of case reports, including serious, non‑serious, clinical trial, and literature cases.
• Assign appropriate MedDRA codes, assess seriousness, expectedness, and causality, and draft regulatory comments.
• Prepare and author aggregate safety reports such as PBRERs, PSURs, DSURs, and signal evaluation documents.
• Interact with internal and external stakeholders to resolve case issues and support audits/inspections.
• Mentor junior physicians and contribute to therapeutic‑area expertise.
• Participate in bid defenses, cross‑functional meetings, and provide inputs for process improvements.

Required profile

• Physician with extensive experience in pharmacovigilance and patient safety.
• Proven ability to lead medical safety reviews and mentor junior staff.
• Strong understanding of global regulatory requirements and reporting obligations.
• Excellent communication skills for interaction with clients, regulators, and cross‑functional teams.

Required skills

• MedDRA coding and terminology.
• Pharmacovigilance processes and adverse event reporting.
• Regulatory compliance and SOP adherence.
• Medical review and causality assessment.